safety and preliminary efficacy of palingen flow amniotic tissue allograft in chronic ulcers of the lower extremities

Conditions: Chronic Ulcer of Lower Extremity

Summary: the purpose of this study is to assess the safety and preliminary efficacy of palingen® flow for the treatment of chronic ulcers of the lower legs and feet.


Eligibility criteria:
inclusion criteria: * able to read, understand and sign the informed consent form (icf) * available and willing to complete all study assessments * at least 12 weeks post lower extremity revascularization procedure, if one has been performed * have chronic ulcer(s) of the lower extremities with the following characteristics: * of diabetic or vascular etiology * duration of ≥4 weeks, unresponsive to soc * ≤20 cm2 in area * extend through the full thickness of the skin but not down to muscle, tendon, or bone * for subjects with vlu: * ulcer area is ≥1.5 cm2 and ≤20 cm2 and with a clean, granulating base with minimal adherent slough * ulcer location is at or above the ankle (malleolus) and below the knee * ulcer location is appropriate for use of compression therapy treatment * for subjects with dfu: * ulcer area is ≥1.5 cm2 and ≤ 20 cm2 and is amenable to off-loading * subject has diabetes mellitus (type 1 or type 2), requiring insulin or oral/injectable medications to control blood glucose levels * glycosylated hemoglobin (hba1c) level at screening is \<12% * adequate circulation to the affected lower extremities * total serum bilirubin, alanine aminotransferase (alt) and/or aspartate aminotransferase (ast), hemoglobin, wbc, and plt count all within limits specified in study protocol * no renal impairment or mild renal impairment, defined as creatinine clearance ≥50 ml/min (by cockroft-gault estimation) * male subjects and female subjects of childbearing potential must use acceptable methods of contraception exclusion criteria: * clinical evidence of ongoing infection and/or receipt of iv, oral, or topical antimicrobials at the baseline visit * wheelchair bound or bed-ridden (ambulatory with assistance is acceptable) * ulceration at the site of amputation * undergoing renal dialysis * known or suspected malignancy in the target ulcer, or a history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancer) * documented history of osteomyelitis at the target ulcer location within 6 months of screening * current treatment or anticipated need for treatment over the course of the study with: * immunosuppressants (including topical or systemic corticosteroids or glucocorticoids) * cytotoxic chemotherapy * growth hormone * oral or systemic antifungal or antituberculosis treatment * history of radiation at the ulcer site * new york heart association class iii or iv congestive heart failure or uncontrolled cardiac dysrhythmia * diagnosis of autoimmune disease(s) (rheumatoid arthritis, lupus, psoriasis, sjogren's syndrome) or arthritis requiring corticosteroid treatment * target ulcer(s) previously treated with negative pressure, hyperbaric oxygen, or tissue engineered materials (eg, apligraf®, epifix® or dermagraft®) or other scaffold materials (eg, oasis, matristem) within 4 weeks prior to screening visit * target ulcer(s) anticipated to require negative pressure wound therapy or hyperbaric oxygen at any time during the study * subjects with vlu who have: * deep vein thrombosis diagnosed within 4 weeks prior to screening visit * refusal or inability to tolerate compression therapy * subjects with dfu who have: * active charcot foot (stable chronic charcot foot is not exclusionary) * ulcers on toes 2, 3, 4, and/or 5 only (ulcer on plantar surface of the great toe only is not exclusionary) * pregnant or breast feeding * allergic to dmso * healing of target ulcer is observed to be ≥35% at the end of the run-in period (between screening and baseline visits) * presence of any condition(s) which compromises the subject's ability to complete this study, including subjects with a known history of poor adherence to medical treatment * subjects who, in the opinion of the investigator, are not able to comply with study requirements * treatment with an investigational drug(s) or device(s) within the 4 weeks preceding screening

Keywords: diabetic ulcer venous stasis ulcer